The invention relates to a system with a surgical needle and a handle.
There are surgical operation techniques in which thick or very thick surgical needles are used, e.g., needles having a diameter from 2 mm to 7 mm. For example, such needles are used in order to insert a band or tape below the urethra of a patient for treatment of stress incontinence as disclosed in U.S. Pat. Nos. 5,899,909 and U.S. Pat. No. 6,273,852, both incorporated by reference herein in their entirety.
When the needle is guided through tissue, considerable forces occur. In handling the needle, the surgeon can use a needle holder or a gripper-like surgical instrument as an aid, but, as a rule, he has to re-apply this instrument to the needle often, which is not convenient. Moreover, unfavorable lever ratios can occur, in particular if the instrument runs oblique with respect to the needle.
It is an object of the invention to provide a possibility for facilitating the handling of a surgical needle, in particular of a thick surgical needle.
The system according to the invention includes a surgical needle and a handle. The surgical needle comprises, in its proximal end region opposite the needle tip, a support section, which is adapted for pushing into the handle. The handle comprises a lumen adapted for holding the support section of the surgical needle and a locking means. The locking means can be switched from a locking position, in which the support section is fixed to the handle, to a release position, in which the support section can be pulled out of the lumen.
When the support section is locked or fixed at the handle, the surgical needle is rigidly and securely connected to the handle. In this state, the handle appreciably facilitates the handling of the needle. For example, by means of the handle, the needle can be held and easily guided through the tissue of the patient. The suture material, tape or a similar object, which is to be pulled through the tissue by means of the needle, can be attached to the shaft of the surgical needle in between the support section and the needle tip, preferably close to the support section, by means of a shrink tubing or other attachment and detachment means as is disclosed in U.S. Pat. No. 6,273,852 B1, incorporated by reference herein in its entirety. If shrink tubing is used as the attachment means, the surgical needle preferably comprises an attachment section for suture material, a tape or similar means, distal to the support section, e.g. a corrugated section of the shaft which can also be provided with a step at which the shrink tubing engages in order to enable a continuous transition between the shaft and the suture material, the tape or similar means.
When using the invention for the method disclosed in the U.S. Pat. No. 5,899,909, after the needle has penetrated the abdomen the needle tip can be grasped by the surgeon by hand (or with a conventional instrument). At this moment, the locking means can be switched from the locking position to the release position, such that the needle can be pulled out of the handle non-abruptly and with a small force effort (or, vice versa, the handle can be retracted from the needle). After releasing the handle, the needle with the suture material, tape or similar means attached to the needle can be completely pulled through the tissue.
The surgical needle can have a diameter of 2 mm to 7 mm, but a different diameter is conceivable as well. Certainly, as is known to those skilled in the art, the surgical needle may take on any variety of cross-sections.
Preferably, the support section of the surgical needle, in its cross-section, at least in a partial region deviates from a circular shape, and the lumen, in its cross-section, is adapted to the support section for securing the surgical needle against torsion. This design enables a torsion-proof connection of the needle to the handle in a simple manner.
In an advantageous version of the invention, the lumen starts at an opening in the distal end region of the handle, and the support section of the surgical needle is adapted to a longitudinal insertion into this opening. The support section of the surgical needle comprises a depression, into which, in the locking position, engages a locking element provided at the locking means of the handle. The locking means comprises a sleeve rotatably mounted in the lumen of the handle. In this preferred embodiment, there is provided at the proximal end of the support section of the surgical needle adjacent to the depression of the support section, a locking protrusion having a non-circular cross-sectional shape. The sleeve of the locking means is rotatable around the longitudinal axis of the lumen from the locking position into the release position and comprises a plate-like locking element having an opening which can be passed by the locking protrusion in the release position, but not in the locking position. Preferably, the locking element is located in the distal end region of the sleeve. The sleeve can be coupled to an actuating lever, which essentially runs in radial direction, the free end of the actuating lever preferably extending through an opening in the handle, which opening allows a rotational movement of the actuating lever and sleeve. The handle can include an engagement means for securing the actuating lever in the locking position.
This preferred embodiment of the invention allows a convenient and safe handling of the surgical needle with one hand. If required, the actuating lever can be moved into the release position, e.g., by means of the thumb, such that the surgical needle can be released from the handle with a small force and virtually without a jerk. Thus, the surgeon requires one hand only in order to operate the system. Another advantage of this embodiment is that it can be immediately recognized by means of the position of the actuating lever whether the locking means is in the locking position or the release position.
Preferably, the handle is made from synthetic material and can be designed as a disposable article. Preferably, the handle has a two-part casing such that the locking means can be easily assembled.
In a preferred embodiment of the invention, the handle, in the area of its proximal end, comprises at least one broadening structure, e.g., two protrusions, which extend into opposite directions and transversely with respect to the surgical needle, which protrusions enable the handle to rest conveniently in the surgeon""s palm or ball of the thumb. The handle can additionally comprise at least one finger application structure, e.g. two wing-like structures extending into opposite directions, which run in parallel to the broadening structures and by means of which the surgeon, e.g. using the index finger and the middle finger, can pull the handle onto his palm such that it securely rests in his hand. Another advantage of this embodiment becomes apparent when the needle is curved. In this case the surgeon can recognize the direction of the leading (distal) end of the needle area in relation to the position of the broadening structure or the finger application structure.
These and other features and advantages of the present invention will become apparent from the following more detailed description, when taken in conjunction with the accompanying drawings which illustrate, by way of example, the principles of the invention.